FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE STIMULATOR
MDR report key: 3163508
·
Received June 11, 2013
Report
- Report Number
- 3007566237-2013-01938
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- May 24, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS AN ISSUE WHERE CONTRACT THREE WOULD GO BAD. IT WOULD SPONTANEOUSLY BE DOING AN OPEN CIRCUIT. THE HEALTH CARE PROFESSIONAL WOULD RE-TORQUE THE SETSCREW DOWN AND ¿THINGS WERE OKAY.¿ THIS ISSUE WAS SEEN TWICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264615 | UNKNOWN IMPLANTABLE STIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |